FDA.reportPublic FDA data

G-Flex

Primary DI
05420051305216
Brand
G-Flex
Company
G-Flex Europe
Model
GF252203
Device description
Sclerotherapy Needle - Calibra
Published
2025-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420051305216PackageGS110In Commercial Distribution
05420051301041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420051305216054200513052165420051305216
05420051301041054200513010415420051301041

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
763193690
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420051305209G-FlexGF2522022025-06-02
05420051305247G-FlexGF2623022025-06-02
05420051305544G-FlexU160C2025-06-02
05420051305568G-FlexU160SC2025-06-02
05420051305834G-FlexU230C2025-06-02
05420051305599G-FlexU230SC2025-06-02
05420051305629G-FlexU422-1802025-06-02
05420051305636G-FlexU422-2302025-06-02
05420051305537G-FlexU120C2025-06-02
05420051302512G-FlexU160PC2025-06-02
05420051305995G-FlexU422-230LC2025-06-02
05420051306008G-FlexGF252203-252025-06-02
05420051306640G-FlexU1602025-06-02
05420051306633G-FlexU2302025-06-02
05420051306398G-FlexU422-230S2025-06-02
05420051306404G-FlexU422-180S2025-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800035704711CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704728CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704841CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704858CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704865CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704872CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704889CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704896CORE-INJECTORINCORE CO., LTDFBK2026-02-06
06974296705915AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706004AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706479AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707131AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707285AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707377AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707315AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707322AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707339AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707346AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707353AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707360AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127812477AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127815362AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385963AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385994AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386144AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386175AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
05420051305209G-FlexG-Flex EuropeFBK2025-06-02
05420051305247G-FlexG-Flex EuropeFBK2025-06-02
05420051306008G-FlexG-Flex EuropeFBK2025-06-02
03600040974919BoNeeColoplast A/SFBK2025-05-20